microRNAs Role in Pre-eclampsia Diagnosis

NCT03562715 | Completed DMC

• 1 other identifier: BC (1870)
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with PE, as valuable markers for PE early prediction.

Conditions

Preeclampsia

Keywords

microRNAs; exosomes; preeclampsia; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• The expression of miRNAs 136, 494 and 495 in exosomes of peripheral blood and UCMSCs conditioned media

  2-3 months

Study Arms (2)

Control group

Blood samples were collected from 100 control with normal pregnancies. Thirty fresh umbilical cord samples of women with healthy pregnancies (n=15) were retrieved during caesarean deliveries and umibilical cord mesenchymal stem cells (UCMSCs) were isolated from Wharton jelly.

Preeclampsia group

Blood samples were collected from 100 patients with PE. Thirty fresh umbilical cord samples of PE patients (n=15) were retrieved during caesarean deliveries and UCMSCs were isolated from Wharton jelly.

Eligibility Criteria

• Age: 23 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

PE group included 100 females with a mean age of 28.77 ± 5.72 years, while control group comprised of 100 females with a mean age of 28.06 ± 5.65 years. All enrolled patients were clinically diagnosed by physical examination and laboratory investigations.

You may qualify if:

• To have an uncomplicated pregnancy:
• gestational age at venipuncture between 20 - 42 weeks
• no medical, obstetrical, or surgical complications
• absence of labor at the time of venipuncture
• delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age

You may not qualify if:

• Patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at biochemistry department Faculty of pharmacy

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: November 28, 2016
• Primary Completion: June 15, 2017
• Study Completion: December 25, 2017
• Last Updated: June 19, 2018

Record last verified: 2018-06